Kornimate/medical-research-clean huggingface dataset:
diagnosis of bile duct strictures

Conditions: Bile Duct Stricture; Cholangiocarcinoma; Pancreatic Cancer; Chronic Pancreatitis

Summary: the purpose of this prospective study is to compare the diagnostic utility of two techniques (brush cytology + fish and brush cytology + free dna analysis) in the diagnosis of biliary strictures. histologic diagnosis (biopsies) in conjunction with clinical and/or imaging follow-up will serve as the gold standard for diagnosis of malignancy. in order to do this the investigators will ask study participants to have a small volume of fluid obtained from the bile duct sent for additional testing at redpath. in some patients additional brushings will be obtained for fish testing (this adds \<2 minutes to ercp and only associated risk is increased procedure duration). the investigators hypothesize that the use of cytology +dna analysis has a higher sensitivity and accuracy when compared to cytology +fish in patients with biliary strictures. primary aim: to compare the sensitivity and accuracy of the two techniques (brush cytology + fish and brush cytology + free dna analysis). histologic diagnosis (histology from biopsy or cytology for fine needle aspiration) in conjunction with clinical and/or imaging follow-up will serve as the gold standard for diagnosis of malignancy. secondary aims: 1. to evaluate the diagnostic yield of malignancy when all three techniques (cytology, fish and dna analysis) are used. 2. to evaluate the added value of biliary forceps biopsies, when used in conjunction with cytology, fish and dna analysis.


Eligibility criteria:
inclusion criteria: 1. patients age: \> 18 years 2. presence of a biliary stricture 3. ability to provide written informed consent. exclusion criteria: 1. severe coagulopathy (inr \> 1.8) or thrombocytopenia (platelet count \<50,000) 2. inability to cannulate the common bile duct 3. presence of altered anatomy (billroth ii or roux-en-y reconstruction)

Keywords: bile duct stricture cholangiocarcinoma pancreatic cancer chronic pancreatitis
individualized studies of triggers of paroxysmal atrial fibrillation

Conditions: Atrial Fibrillation Paroxysmal

Summary: the i-stop-afib study will test the comparative effectiveness of using n-of-1 trials vs. symptom surveillance alone to reduce atrial fibrillation (af) episode frequency and severity and improve quality of life for af patients. the study will involve randomizing almost 500 paroxysmal af patients to either af episode tracking versus engaging in testing the relationship between participant-selected triggers and af episodes utilizing a mobile-app based n-of-1 study design. both groups will complete a validated survey to assess af severity, essentially a measure of quality of life while living with af, before and after a 3 month testing period.

n-of-1 trial arm: participants will use the eureka mobile application and alivecor device to execute at least one n-of-1 trial with the goal of identifying and better controlling their af triggers. each n-of-1 trial will last a total of 6 weeks and will include up to 3 periods of trigger exposure and 3 periods of trigger elimination with each exposure/elimination period lasting 1 week. participants will be randomly assigned to start their trial with a period of either trigger exposure or elimination. during each n-of-1 trial, participants will track daily af duration and severity, daily mood and sleep quality, daily alivecor tracings and daily trigger exposure. at the end of each trial, participants will be able to review their trial results which will include visualizations of their daily af symptom and trigger tracking over time. after completing a trial, participants will be instructed to implement any lifestyle changes they deem appropriate based on what they learned from the results of their trial. participants will implement these changes for a period of 4 weeks during which they will continue to track af episode duration and severity via the app. at the end of the 4-week lifestyle change period, participants will complete the atrial fibrillation effect on quality of life survey (afeqt) and will then have the option of testing another trigger or ending their study participation. symptom surveillance arm: participants will use the eureka app and alivecor device to record daily af duration and severity, daily alivecor readings and daily mood and sleep quality for a period of 10 weeks. participants will be able to visualize their af, sleep and mood data in real time and will receive a weekly summary of their data via the eureka app.at the end of the 10-week data tracking period, participants will complete the afeqt survey and will then have the option of either ending their study participation or crossing over to the n-of-1 trial arm to test their triggers.

Eligibility criteria:
inclusion criteria: * symptomatic paroxysmal af * a smartphone exclusion criteria: * non-english speakers * children (age \< 18 years) * patients with plans to substantially change af management (such as with ablation or change in antiarrhythmic drugs) over the ensuing 6 months * unwillingness to test af triggers. * patients who have had an av node or av junction ablation
a comparison of two color contact lenses in habitual clear contact lens wearers

Conditions: Myopia

Summary: the purpose of this study is to evaluate the comfort of color contact lenses in a population of clear contact lens wearers who have an interest in wearing color contact lenses.


Eligibility criteria:
inclusion criteria: * willing to sign an informed consent document or assent, if applicable. * vision correctable to 20/30 snellen (feet) or better in each eye at distance with pre-study contact lenses. * manifest cylinder (at screening) less than or equal to 0.75 diopters (d) in each eye. * successful wear of clear/handling tint, single-vision spherical, bi-weekly/ monthly replacement soft contact lenses in both eyes during the past 2 months for a minimum of 5 days per week and 8 hours per day. * requires spherical contact lenses within the available range of powers (i.e.,-1.50d to -5.00d in 0.25d steps). * interested in wearing contact lenses that change the appearance of the color of the eyes. * other protocol-specified inclusion criteria may apply. exclusion criteria: * any anterior segment infection, inflammation, disease or abnormality that contraindicates contact lens wear (within 7 days of enrollment, or current). * history of herpetic keratitis. * any use of systemic or ocular medications for which contact lens wear could be contraindicated including any use of topical ocular medications that would require instillation during contact lens wear, except for rewetting drops. * corneal vascularization greater than 1 millimeter (mm) of penetration. * habitual lenses worn in an extended wear modality (routinely sleeping in lenses overnight for 1 night per week or more) over the last 3 months prior to enrollment. * previous corneal or refractive surgery or irregular cornea. * monovision and monocular (only 1 eye with functional vision) or fit with only 1 lens. * anisometropia ≥1.50d (study contact lens prescription). * history of intolerance or hypersensitivity to any component of the test articles. * eye injury or ocular or intra-ocular surgery within the last 6 months (excluding placement of punctal plugs). * participation in any clinical study within 30 days of visit 1. * other protocol-specified exclusion criteria may apply.

Keywords: contact lens vision care daily wear color contact lens
the best timing of delivery in women with gdm study

Conditions: Gestational Diabetes; Induction of Labor Affected Fetus / Newborn

Summary: the investigatiors aimed to conduct a well-designed rct to firstly focus on gdm women controlled with only diet and exercise, and provide an optimize process on their timing and mode of delivery

gdm is a common complication of pregnancy and even mildly hyperglycemia could significantly affect fetal growth. optimal delivery timing in women with gdm remains controversial. this decision process involves balancing the potential for complications that are caused by increased interventions with the benefit of avoidance of future adverse outcomes. thus, the aim of the present trial is to explore the best management on the timing of delivery of pregnant women with gdm that controlled with only diet and exercise, which can both decrease the risk of macrosomia and the risk of cesarean delivery.

Eligibility criteria:
inclusion criteria: * singleton pregnant women * in vertex presentation * gdm that is controlled with only diet and exercise * at 37 weeks 0 days to 37 weeks 6 days of gestation * more than 18 years old * have no other contraindications to vaginal delivery. exclusion criteria: * prior caesarean section or myomectomy * any known contraindications to vaginal delivery * uncertain gestational age * non reassuring foetal wellbeing necessitating delivery * maternal pregnancy-related disease necessitating delivery (any hypertensive disorder, cardiac disease, renal insufficiency、immune diseases, et al.) * placenta previa, accreta, vasa previa * known foetal anomaly * negative reproductive history * ruptured membranes or known oligohydramnios (defined as afi \< 5 or mvp \< 2 ) before 37weeks 6 days of gestation * fetal growth restriction, defined as efw \< 10th percentile * known hiv positivity because of modified delivery plan * signs of labor (regular painful contractions with cervical change) before 37weeks 6 days of gestation.

Keywords: induction caesarean section fetal weight bishop score
pediatric oncology recovery trial after surgery

Conditions: Pelvic Cancer

Summary: pediatric oncologic recovery trial after surgery (ports) trial is an investigator-initiated, multicenter, multidisciplinary prospective case-control study of the implementation of an enhanced recovery after surgery (eras) protocol at five tertiary-care pediatric hospitals in pediatric patients undergoing abdominal or retroperitoneal surgical resections for cancer. a pilot phase will determine characteristics of a successful protocol implementation and an exploratory phase plans to examine adherence, objective patient outcomes, and patient-reported outcomes. after completing primary enrollment, this collaborative will continue to enroll patients in the shared data registry and continue to refine the underlying eras protocol developed for this project.

two arms: historical patients eras patients number of patients: 288 primary outcome · number of 90-day complications by clavien-dindo classification secondary outcome(s): * adherence to eras protocol items with # of items achieved (out of 20) * length of stay * re-admissions within 90 days * re-operations within 90 days * number of visits to the emergency room within 90 day period * minimum, mean, maximum daily pain score during first 7 days after surgery * mean daily iv morphine equivalents (mg/kg) usage during first 7 days after surgery * recurrence free survival (months) * overall survival (months)

Eligibility criteria:
inclusion criteria: * patients undergoing operations at a pediatric hospital setting aged 1 month or older * parents of patients undergoing operations at pediatric hospital settings aged 1 month or older * undergoing urologic reconstruction, ureteral operations, pyeloplasty, intraabdominal on-cologic resections, urachal remnant excision, bariatric operations, pectus surgery, ap-pendicitis, orthopedic or neurosurgical operations and inflammatory bowel disease proce-dures * providers of patients undergoing surgery in pediatric settings exclusion criteria: * less than 1 month in age
use of cefiderocol in the management of gram-negative infections

Conditions: Gram-Negative Infection

Summary: the aim of this study is to describe the use of cefiderocol in the management of gram-negative infections (gnis) in participants treated through the early access program (eap) in spain.

this is a multicenter, retrospective, chart review of existing medical records in participants who received cefiderocol for a gni as part of the shionogi eap. access to cefiderocol was granted as medication not approved in spain subject to rd 1015/2009, which dictates that each case is approved on an individual basis by the spanish agency of medicines. this study will be conducted at spanish sites where cefiderocol was supplied via the eap, beginning in 2018.

Eligibility criteria:
inclusion criteria: * have received first course of cefiderocol. * have received treatment for at least 72 hours (complete) with cefiderocol as a part of clinical compassionate management, requested in the eap. exclusion criteria: * enrolled in any clinical trial of an investigational product. * documented acinetobacter spp infection. * incomplete medical records for the following essential data elements: * cefiderocol usage (dose, duration, frequency) * data to be able to determine clinical success (primary objective) * co-infection with a gnb resistant to cefiderocol in 28 days of the initial dose of cefiderocol.

Keywords: cefiderocol early access program spain
speech adaptation when using mouthguards

Conditions: Rugby

Summary: the aim of this study is to evaluate the speech performance of professional rugby players when using custom-fitted mouthguards over a six-month period. consented players will be given custom-fitted mouthguards and they will be instructed on the use and care of the mouthguards. at five time points: baseline, immediately following mouthguard use (t1), one-week after- (t2), one-month after- (t3) and six-month after use (t4), participants are required to pronounce four selected phonemes. three recordings will be made for each phoneme. spectrspectrographic analysis will be performed to assess the acoustic characteristics of the sound. concurrently, they will be asked to fill up a questionnaire on self-assessment of oral impairments. throughout the six-month period, the compliance of wearing mouthguards and the occurrence of dental trauma during training will be monitored on-site by the researcher or if not available, an assigned coach. a 24-hour helpline will be provided as a surveillance tool to monitor problems with mouthguards and dental trauma.

rugby exposes players to increased risk of dental trauma. thus, mouthguard use is recommended to provide a resilient surface for shock absorption and impact dissipation. however, some discontinued using mouthguard complaint that general discomfort and speech disturbance are the main barriers to their compliance. the nuisance is largely due to their use of poorly-fitted stock or boil-and-bite mouthguards. therefore, the primary objective of this study is to evaluate speech adaptations when using custom-fitted mouthguards. the secondary objective is to assess the incidence of dental trauma within the six-month duration of mouthguard use. a prospective study will be carried out at the national sports institute. during the first day (t0), a workshop on the prevention and management of dental trauma will be carried out. then, dental examination, dental impression, and recording of baseline speech performance will be performed. during the second visit (t1), mouthguards delivery, self-assessment of oral impairments, and speech recording will be carried out. after 6-months of monitoring (t2), all participants will be called again to fill in the self-assessment form and final speech performance will be recorded. data analysis will be carried out to evaluate the self-assessment of speech performance and digital sonography of speech recordings over time. also, the incidence of dental trauma will be reported.

Eligibility criteria:
inclusion criteria: 1. men aged between 18 and 35; 2. actively playing rugby; 3. currently playing in malaysia rugby union; 4. native speakers of malay (national language), with the ability to read and write in malay fluently; and 5. without any history of either speech or hearing impairment. exclusion criteria: 1. retired players; 2. national players who did not play rugby within the last six months of the recruitment date; and 3. players with cleft lip and/or cleft palate; and 4. players with any history of either speech or hearing impairment.

Keywords: dental trauma rugby mouthguard speech contact sports
physical health improvement intervention for people admitted to mental health service

Conditions: Physical Health; Mental Illnesses; Chronic Diseases

Summary: this study aims to codesign and implement a physical health improvement behaviour change intervention for people being treated for a mental illness in a mental health inpatient unit of a regional hospital.

people in regional areas with mental illness suffer high prevalence of preventable chronic health conditions. multi-morbidity in people with mental illness contributes to a reduced life expectancy of up to 20 years. many physical diseases are preventable and/or reversable if risk factors are identified early, and the right health promotion tools and interventions are provided. addressing such a complex issue for people with mental illness requires an approach which is adaptable, has been co-designed with clinicians and consumers and is comprehensive to target individualised health behaviours. this research uses the health improvement profile (hip) tool to help clinicians (e.g. nurses, doctors) to assess patients physical health and identify risk factors or early signs of chronic disease. using the health improvement profile (hip) tool during admission the clinicians will work with clients to implement the most suitable health promotion tools to help improve physical health. using implementation research methodology and following the consolidated framework for implementation research (cfir) the study is broken into the following 4 stages: * identify * adapt - codesign/adapt health improvement profile (hip) intervention and develop user training * implement - into clinical areas to assist developing personalised health improvement profile (hip) * evaluate - using both qualitative and quantitative data to determine feasibility of the health improvement profile (hip) and implementation in a regional health service

Eligibility criteria:
inclusion criteria: * this study is being carried out in an inpatient service therefore clinical staff must be registered by their professional governing body with a minimum of 6 months employment at the service or within the region to participate in stages 2 and 3. graduate clinicians with less than 6 months working experience will be excluded from the study. clinicians new to the region with less than 6 months working experience in location will be excluded from the study. clinical roles within the facility include but not limited to: * nurses (enrolled or registered) * psychiatrists * psychologists * social workers clients of the inpatient mental health service eligible to be included in the study must be: * over the age of 18 years * able to read, understand and speak english * a current or previous user of the hospital's services * a current or previous user of the inpatient services * a carer of someone who is a current or previous user of the inpatient mental health service * able to provide consent * not an employee * not a health professional

Keywords: implementation research health improvement profile
the outcome of inserting intercostal tube or pleurodesis for malignant pleural effusion

Conditions: Malignant Pleural Effusions (Mpe)

Summary: approximately half of all patients with metastatic cancer develop a malignant pleural effusion which is likely to lead to a significant reduction in quality of life secondary to symptoms such as dyspnoea and cough. the aim of pleurodesis in these patients is to prevent re-accumulation of the effusion and thereby of symptoms,and avoid the need for repeated hospitalization for thoracocentesis. numerous clinical studies have been performed to try to determine the optimal pleurodesis strategy, and synthesis of the available evidence should facilitate this. the treatment of mpe is aimed at palliating symptoms since no intervention has been shown to improve survival in this population and since survival is generally limited in cancers that have spread to the pleural space. in this palliative setting, only patients symptomatic from their mpe should be submitted to further intervention. as well, further interventions in symptomatic patients should be limited to those patients who have experienced symptomatic improvement following initial therapeutic thoracentesis. the two main treatment approaches to mpe are to obliterate the pleural space via a pleurodesis procedure or to chronically drain the pleural cavity with intercostal tube. the aims of this review were to ascertain the optimal procedure in cases of malignant pleural effusion in terms of patients' quality of life post procedure, recurrence of effusion.


Eligibility criteria:
inclusion criteria: * all patients presented with malignant pleural effusion to assiut university hospital regardless of sex and age exclusion criteria: * all patients presented with pleural effusion other than malignant pleural effusion, including patients with debilitating diseases and terminal patients.
telemedicine in atrial fibrillation: randomized clinical trial in primary care (atrialconnect)

Conditions: Atrial Fibrillation

Summary: atrial fibrillation (af) is the most common cardiac arrhythmia in the world, with a large consumption of health resources. telemedicine represents a new model of care, facilitating the individual approach to each patient and reducing costs and complications. this is an an open-label, randomized, multicenter, clinical trial aiming to analyze the use of telemedicine with af patients in real clinical practice at primary care in terms of efficacy, efficiency, patient perception and professional satisfaction. the intervention will be based on the use of the ti.care app as the telemedicine support, in addition to the usual care. the follow-up will be carried out for 12 months.

background: atrial fibrillation (af) is the most common cardiac arrhythmia in the world, with a prevalence between 2-4%. given the increase in prevalence, its associated morbidity and mortality, and the large consumption of health resources there has been a need to adapt health care models. telemedicine and the use of mobile devices represent a new model of care for chronic patients, facilitating the individual approach to each patient and reducing the disability associated with their chronic pathology. objective: to analyze the use of telemedicine in patients with atrial fibrillation in real clinical practice in primary care trying in terms of efficacy (blood pressure control, incidence of ischemic stroke, incidence of bleeding), efficiency (number of visits to the clinic, hospitalizations, costs of care), patient perception (quality of life, therapeutic adherence, satisfaction with the mobile app) and professional satisfaction (satisfaction with the mobile app and benefits of its use in the clinic). methods: the investigators propose to conduct an open-label, randomized, multicenter clinical trial. the intervention will be based on the use of the ti.care app as the telemedicine support, in addition to the usual care with their primary care physician (pcp). the control group will perform the usual follow-up with their pcp. the follow-up will be carried out for 12 months, and is proposed as an effective and cost-efficient improvement for the national health system and for the patient. key words: telemedicine, mobile applications, atrial fibrillation, primary health care.

Eligibility criteria:
inclusion criteria: * patients over 18 years of age diagnosed with af. * without difficulties in using the mobile app or patients with difficulties in using the mobile app but with good family or caregiver support, who understand its use. exclusion criteria: * terminally ill patient. * refusal to participate on the part of the patient * difficulties in understanding the contents of the mobile app (cognitive impairment, dependence for activities of daily living, etc.) and no enabling family support

Keywords: telemedicine atrial fibrillation primary care patient perception quality of life efficacy efficiency job satisfaction patient safety mobile applications